Trials / Completed
CompletedNCT02677077
Clinical Disease Activity With Long Term Natalizumab Treatment
MRI and Clinical Disease Activity in Patients Treated Long Term With Natalizumab
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 277 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to retrospectively investigate the proportion of participants free of new or enlarging fluid-attenuated inversion recovery (FLAIR) lesions over time in approximately 300 Relapsing-Remitting Multiple Sclerosis (RRMS) participants with regular MRI follow-up, who have received natalizumab ≥24 month from two different observational cohorts: 1) approximately 230 participants from the Czech Republic; and 2) approximately 70 participants from Belgium. The secondary objectives of this study are as follows: Brain volume change by various measures; Changes in the number and volume of magnetic resonance imaging (MRI) lesions; No evidence of disease activity (NEDA) with and without brain volume change.
Detailed description
Natalizumab will not be provided to participants by Biogen as a part of this study. Participants will remain on natalizumab therapy as prescribed by their physician.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | natalizumab | Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic |
Timeline
- Start date
- 2015-12-31
- Primary completion
- 2016-08-18
- Completion
- 2016-08-18
- First posted
- 2016-02-09
- Last updated
- 2019-01-04
Locations
4 sites across 2 countries: Belgium, Czechia
Source: ClinicalTrials.gov record NCT02677077. Inclusion in this directory is not an endorsement.